iBusiness, 2013, 5, 118-122
http://dx.doi.org/10.4236/ib.2013.53B025 Published Online September 2013 (http://www.scirp.org/journal/ib)
Study of Problems and Countermeasures on Ethical
Review of Research in China
Xidong Deng1, Lingyan He2
1School of Economics and Management, China Three Gorges University, Yichang, China; 2School of Economics and Management,
China Three Gorges University, Yichang, China.
Email: 1067203988@qq.com, helingyanzi@163.com
Received July, 2013
With the rapid development of biotechnology, ethical issues of scientific activ ities are mo re and more serious, while the
ethical review as the main means of suppressing research ethics problems, it also has many problems in the process of
practice. This article from the ethics review committee’s organizational structure, operation specifications, capacity, the
scope of review and external regulation summarize the main problems of China's research ethics review, and on this
basis, we put forward the corresponding countermeasures, hoping to provide certain reference of our country's research
ethics review practice, and to better safeguard the healthy development of our country's scientific research.
Keywords: Research Ethics; Ethical Review Committee; Ethical Review
1. Introduction
1.1. The Necessity of Research Ethics Review
With the rapid development and deepening of biotech-
nology, the contemporary scientific research is combined
closely with commerce, market, financing funds, and the
purpose and test pattern of the biomedical trials involv-
ing the human body has occurred and is undergoing a
profound change, there are complex links between the
various stakeholders, making scientific research process
hide complex interst conflicts, many scientific research
infringe upon the rights of the subjects, the project ap-
proval, design implementation, papers publishing, and
the results reporting process filled with complex and
sharp ethical issues. When scientific activities are no
longer simply meaning the pursuit of objective knowl-
edge, it is the value of a complex ethical connotation of
social practice, and the value and purpose of human
should be the inner dimension of scientific research, the
necessity of introducing the ethical constrains into the
scientific research will be understood[1].
To some extent, ethical review can keep scientific re-
search objective, fair and according with ethical re-
quirements. The ethical review of scientific research re-
flects on the respect and protection to the dignity, inter-
ests and rights of subjects, is a necessary step to promote
scientific research to achieve scientific and ethical stan-
dards, playing a more and more important role for the
healthy development of various research institutions.
Ethical review can be strict to review process and be
norms of scientific research from the origin of scientific
research- project application process [2], so that the re-
searchers will follow ethical principles in scientific re-
search activities. Strictly controlling the test scheme and
informed consent during the review process, ask them to
put the subjects interests first, to maximize the protection
of the rights of subjects. Above all, ethical review plays
an important role and significant to the healthy develop-
ment of our country’s scientific research.
1.2. The Necessity of Research Ethics Review
Modern ethics review originated in Western, in 1946
"Nuremberg Code" make regulations for human medical
trials to follow the ethical principles, and put forward
four principles of human medical trials. In 1974 the U.S.
Congress named the agency reviewing those research
program involving human subjects Institutional Review
Board, abbreviated as IRB[3]. Since then, the ethical
review system has been running for more than thirty
years in the West, and become the important measure to
protect human research subjects.
Compared to Western countries, ethical review of our
country have a late start, in the 1990s, to adapt the need
to the rapid life development of biotechnology, in 1991
when carrying out a Sino-US cooperation in biomedical
research project, in order to be able to continue to carry
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Study of Problems and Countermeasures on Ethical Review of Research in China 119
out research, at the request of the United States, we es-
tablished the first ethical review committee. Subse-
quently technology and health authorities recognize the
importance of ethical review, and then increasing the
force of review biomedical research involving human
research and application. In general terms, the construc-
tion of ethical review committee has experienced two
stages: the first stage (abou t 1987 to 1997) ,during which
the ethical review committee is mainly based on the hos-
pital, and is named for ho spital ethical committee, which
is built in hospital, and staffed by a multidisciplinary
medical ethical decision-making advisory organization,
and the functions basically grouped into four categories:
education and training, consulting coordination, supervi-
sory review, ethics policy research, getting more atten-
tion to ethical review, and there are some initial transla-
tion, introduction and discussion, but not to involve ethi-
cal review of research on human issues widely; second
phase (after 1997) mainly focuses on the growing num-
ber of ethics review committee for biomedical research
involving human subjects and ethical review of pharma-
ceutical research, at the same time, the distribution of
ethical review committee has also changed, the estab-
lishment not only in hosp itals, and most medical schools,
large medical research organizations have begun to focus
on establishing ethics review committee to review the
ethical issues of biomedical research, and some biologi-
cal medical technology companies have also set up the
Since our country introducing and learning ethics re-
view regime has been twenty years, but the establishing
and operating environment of ethical review regime in
China is different from the ethical concept, theoretical
foundation, cultural heritage and social environment in
the West, and the working practice of ethical review
committees around the country highlights the distinct
characteristics with the West, a considerable part of the
ethics review committee just threw a coat of ethical
review, all kinds of about 500 ethics committee at all
levels there is about only 20% with reasonable structure,
the conditions and the ability to work independently,
work procedures norms. Our ethics review system is im-
perfect: organizational construction and ethical review
specific issues are increasingly exposed, and the validity
of ethical review committees is eroded by many factors,
so that the task of building ethics committee of stan-
dardization construction is urgent. In the context of the
rapid development of biomedical research, how to be in
line with international standards, build research ethics
review system with Chinese characteristics and promote
the healthy development of biomedical research, is both a
practical problem needing to be solved and a theoretical
problem needing in-depth study.
2. The Analysis of Research Ethical Review
2.1. Organization Building: Lack of
According to the experience of Western countries, the
ethical review committee should be an independent or-
ganization, but in fact, in China's current ethical review
system, none of our ethical review committee is com-
pletely independ ent, and they are affiliated with universi-
ties, research institution s, hospitals and health authorities ;
ethical review activities can not be completely inde-
pendent, researchers mostly from the unit, the agency
with considerable acad emic authority makes the reviewer
may be not made objective judgment. Meanwhile, one
characteristic of the composition of our country’s ethical
review committee is that the government leaders of the
institutions as the chairman or members of ethical review
committee, because the clinical trial will bring a large
number of research funding and reputation to research
institutions, such as universities, hospitals and research
institutions, so that the ethical review committee in pro-
tecting the interests of subjects will inevitably consider-
ing the interests of research institutions. The tension be-
tween the two tend weaken the insistence of the basic
purpose of ethical review committee. It’s usual to affect
the objectivity and impartiality of the ethical review re-
sults because of taking the interests of institutions into
consideration, and have to take into account the interests
of both the subjects and the research institutions, which
is conflict with the original intention of establishing
ethical review committee. Such interest conflict could
threaten the independence of ethical review. The review
can not be in the proper review process, free from exter-
nal influence, and in accordance with the ethics and the
basic purpose, make independent judgment and decision,
and then affecting the independence of ethical review.
2.2. Operating Specifications: Lack of Standard
Operating Procedures
Due to ethical review committee in China starting rela-
tively late, and imbalance development, the current stan-
dard and specifications of ethical review are still at the
exploring stage. Ethical review committee generally fol-
lows the Declaration of Helsinki and other international
norms, but such documents are demands principled and
highly generalized, without detailed implementation
specification for specific studies, and are difficult to
grasp in practice. Laws and regulations of our country
are made mainly according to the relevant principles of
international guidelines, making no regulations or guide-
lines for specific conten t with procedural, operability and
normative, making review decisions too subjective, dif-
Copyright © 2013 SciRes. IB
Study of Problems and Countermeasures on Ethical Review of Research in China
ferent ethical review committee with different review
standards, the impartiality, authority and scientificity of
the review be questioned.
2.3. Members Capability: Lack of Continuing
Education and Training
Currently, the professionalism of members of ethical
review committee and competence of ethical review
work are not strong en ough, an d the ethical fo undatio n of
most research ethical committees is weak, lack of neces-
sary knowledge and review capacity[4]. Although in re-
cent years, the training program of research ethics keeps
increasing, it’s still far to meet actual needs. The ethical
review committee itself is lacking of resources to provide
training, so members have no way to get education. This
greatly limits the ethical review committee to improve its
own review capabilities.
2.4. Review Scope: Lack of Feedback and Track-
ing Review
Most review of ethical review committee is limited to the
initial research programs, and after pass the review and
enter through the pilot ph ase, the ethical review commit-
tee is seldom to do tracking review and oversight for
specific implementation process, informed consent proc-
ess and the protection of th e real situation of the subjects,
and even lack of necessary attention and tracking review
for the changes, modifications and other issues of in-
formed consent of research projects, and rarely asking
researchers to submit the changes and other relevant
feedback information[5]. Meanwhile, after raising the
questions in the tracking, it’s always lacking of the
tracking review for problem-solving situations, making
some problems found can not really be solved. This has
resulted in ethical review committee not clearly under-
standing the real situation of informed consent and the
protection of the subjects, to a certain extent, making
ethical review as empty shells.
2.5. External Oversight: Lack of Effective
Supervision and Management Mechanism
In other countries, the regulatory model for ethical safe-
guards has attracted a lot of attention: ethical review has
evolved into a "research ethics industry." Western coun-
tries with complete ethics review system all have a spe-
cialized agency to oversee the operation of ethical review
committee, such as the U.S. OHRP, UK NRES and the
Swedish central ethical review committee. In our country,
the ethical review committee is mainly managed by the
Ministry of Health and the Food and Drug Administra-
tion at the macro level, and without a regulatory ethics
review committee. Compared with foreign countries, in
our country ethical review committee has neither formed
external supervision mechanism to ethical review com-
mittee, nor formed a self-assessment procedure. We lack
specialized agencies to evaluate and assess the situation
of the implementation of ethical review, ensure the
committee to act by chapter, and punish irregularities.
3. Countermeasures and Suggestions
3.1. To Strengthen the Construction of Certified
System of Ethical Review Committee
The low threshold to establish ethics committee is one of
the roots resulting in uneven quality of each ethical re-
view committee [5]. To improve the access threshold and
practice quality, creating a third-party certification as-
sessment sys-tem is one of important measure to further
improve the capacity and quality of ethical review com-
mittee. To move in the direction to establish a profes-
sional focus in order to ensure ethical review to operate
healthy in tracks of high efficiency and high quality, will
be more conducive to the major eth ical issues about sub-
jects protection with enough voice and execution. It re-
quires specification of barriers to entry and continuously
evaluation of their ability to practice, eliminating those
committees undertaking fewer projects, weak capacity to
review. Currently a number of ethical review committees
invite foreign counterparts or in stitutions to help improve
ethical review capacity, which indicates that our country
have urgent desire and pursuit to improve the capacity
for ethical review and management, and it’s urgent to set
up a ethical review evaluation criteria system combined
with international standards and appropriate to the cul-
tural, economic, racial, religious characteristics.
3.2. To Establish Standard Operating
Whether we can fulfill the review functions with high
efficiency and high standards and ensure the safety and
interests of subjects, depends on the efficient manage-
ment system and operational standard operating proce-
dures. Therefore, in order to improve the quality of ethi-
cal review committees, ethics committees should have a
complete organization and system, should develop com-
prehensive censorship and procedures, establish standard
operating procedures SOP. Based on both inside and out-
side relevant laws and regulations, combining with the
situation of research and project review, pre-practical
experience of the ethical review committee, and drawing
on foreign experience, design the SOP for local ethical
committee system to control the quality of ethical review.
But it’s important to note that only the most optimal de-
sign through constant practice, could be realized under
current, specific conditions can be called standard oper-
ating procedures, we should focus on operability and
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Study of Problems and Countermeasures on Ethical Review of Research in China 121
In practice, standard operating procedures can be di-
vided into the following seven sections: the design of
standard operating rules and guidelines; the structure of
the ethical review committee; the ways and category of
ethical review; ethical review processes; various ethical
review processes; office management, including commu-
nication records; document and file management.
3.3. To Strengthen the Training and Continuing
Education for Members
With the development of scientific research, the ways
and methods of ethical review are constantly updated,
regular, continuous and standardized training for ethical
knowledge has a crucial role in comprehensively im-
proving the professional level for the ethical committee
members to carry out the ethical review[6]. Through
training, on a understanding level further improve the
ethical review staff’s understanding to the protection of
subjects’ interests on human test, and be clear to the the
necessity and importance of ethical review; On a techni-
cal level regulate the process of ethical review, enhance
the professional knowledge and skills of ethical review ;
improve the quality of ethical review, improve manage-
ment capacity, improve document and file management
to ensure the quality of ethical review.
Therefore, ethical review committee needs to take full
advantage of existing resources, through various forms to
train for members. Relying on relevant academic institu-
tions, medical schools and medical technology groups,
etc., organization of training courses, conferences and
seminars, train on the ability of to review and relevant
laws and regulations for members, and strengthen the
understanding of review process, review highlights to
improve the skills of ethical review committee. In addi-
tion, we should strengthen exchanges, build homes in-
terpersonal, inter-provincial and international learning
exchange platform for the exchange of learning and
training. Establish a standard research ethics continuing
education system, the level of professional ability as the
key factor to assess each agency. We may consider to
establish qualification authentication mechanism for
members, those who have the appropriate ability could
be in, thereby improving the professionalism and effec-
tiveness of ethical review overall.
3.4. To Establish the Feedback and Tracking
Review Mechanisms
An ethical review, the ethical review of the clinical in-
vestigation is not just limited to the examination before
the study began, but also including the tracking review
after the study began, including review, repair positive
case review, annual/regular tracking review, serious ad-
verse events review, contrary to program review, review
of early termination, concluding review. Tracking review
of an ethics review is an important part of ethical review,
to some extent, its practical significance is even beyond
the ethical review itself. Tracking review is a research
project within the framework of the ethical review im-
plementation through effective safeguards, can ensure the
implementation of research projects accord with the ap-
proved plan, is the core means to ensure subjects’ inter-
ests, to protect medical research and scientific credibil-
ity[7], to enhance the quality of tracking the review, it is
necessary to strengthen the ethical review committee of
supervision and management. In the tracking review
process, taking into account the report of the researchers
active inherent defect, should subjects feedback deserves
Our country can learn from the U.S. experience, re-
quiring a research project on human trials to determine
the person responsible for understanding the subject
concerns, answering questions and record before the ap-
plication submitted to tests, and build a scientific feed-
back mechanism to solve the feedback problem of sub-
jects reasonably.
3.5. To Speed up the Construction of Regulatory
The key of ethical review is to establish ethics review
system, build ethical review committees, and implement
the ethics review. The ability of ethical review com-
mit-tee determines the construction level of the ethical
re-view platform, but the construction of ethical review
platform must not be limited to set up a ethical com-
mit-tee, the smooth operation need for a comprehensive
operation supervision system as a guarantee[8]. The ex-
ternal regulatory and its own review ability of ethical
review committee are complementary and mutually re-
inforcing. To improve our current ethical review com-
mittee management mechanism, need to establish a spe-
cial institution independent of the Drug Administration,
Ministry of Scientific Research and the Ministry of
Health responsible for management and supervision for
the ethical re-view committee, and gradually establish
more comprehensive regulatory system to carry out qual-
ity assessment and quality promotio n project. This is one
of the most important direction for the ethical review
committee improving and d eveloping itself. Based on the
international ethical review, supervision and evaluation
standard, en-sure the authority, ind ependence, objectivity
and impartiality of ethical review, to avoid the injustice
resulting from the interests confilt between various insti-
tutions. The content of the regulation for ethical review
committee is of multifarious, we should determine the
content of regulation based on the main problems ethical
review committee facing to, including qualification,
standard operating procedures, ethical independence,
Copyright © 2013 SciRes. IB
Study of Problems and Countermeasures on Ethical Review of Research in China
Copyright © 2013 SciRes. IB
tracking review, conflict of interests, training and the
availability of education etc.; We need to gradually in-
crease supervision in these aspects, to realize the good
interactive development between external supervision
and internal review ability .
Specifically, first, refine the regulatory approach; sec-
ondly, require ethical review committees to make a deci-
sion in writing in order to prepare for post-review, and
require researchers to submit a written report to the ethi-
cal review committee to protect the rights of subjects
better; last, if regulators find problems of ethical review
committee, shall order it to make corrections, if it
dam-ages to the rights of subjects, shou ld notify aborting
human medical trials; if find serious problems, should
have a deadline for correction, if not, should suspend its
ethical review qualifications[9].
4. Summary
Social’s progress and development is inseparable from
scientific research, but research activities involved in a
lot of hidden ethical issues because of the conflict of
interests among all stakeholders. Ethical review commit-
tee promotes research activities to develop healthily and
normatively, but it is restricted by various factors in the
process of practice, thus affect the quality of ethical re-
view. It requires that we comply with international norms
and shared ethical guidelines combined with domestic
laws and regulations, through the construction of ethical
review board-certified system, establish and implement
standard operating procedures of the ethical review
committee, and strengthen the training and continuing
education for members, establish feedback and tracking
mechanisms, accelerate the monitoring system to im-
prove the quality of ethical review, quality improvement
will be more conducive to promote the common devel-
opment of ethical review committees, and then protect
the healthy development of research activities.
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